RecruitingPhase 3NCT06658002

Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A


Sponsor

University of California, San Francisco

Enrollment

150 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if adjunctive topical Cyclosporine A eye drops combined with standard of care topical Natamycin treatment improves vision outcomes in patients with fungal keratitis.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Inclusion is based on presenting acuity, not ulcer size.
  • Inclusion of 20/40 = 6/12 = 0.3 Log MAR and 20/400 = 3/60 = +1.3 Log MAR.
  • Smear or culture positive for fungal keratitis, any length.
  • Age 18 years.
  • Willing to participate in study.

Exclusion Criteria10

  • Co-infection with bacterial or viral keratitis.
  • Corneal perforation.
  • Requiring therapeutic keratoplasty for fungal keratitis.
  • Unwilling or unable to follow up (e.g., living too far from hospital).
  • Presenting acuity better than 20/40 = 6/12 = 0.3 Log MAR or worse than 20/400 = 3/60 = +1.3 Log MAR.
  • Subjects taking cyclosporine at any concentration on presentation.
  • Acuity worse than 20/200 = 6/60 = +1.0 Log MAR in unaffected eye.
  • Pregnant women.
  • Penetrating Keratoplasty.
  • Presents with a 0-7 day history of topical steroid.

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Interventions

DRUGCyclosporine A

Participants with smear or culture proven fungal keratitis are treated for a minimum of 48 hours with topical natamycin and then randomized in a 1:1:1 ratio to receive either topical Cyclosporine A (CsA) 0.1%, 2% or placebo for 4 weeks. Natamycin is continued until the ulcer has healed.

OTHERPlacebo Comparator: Placebo

Participants with smear or culture proven fungal keratitis are treated for a minimum of 48 hours with topical natamycin and then randomized in a 1:1:1 ratio to receive either topical Cyclosporine A (CsA) 0.1%, 2% or placebo for 4 weeks. Natamycin is continued until the ulcer has healed.


Locations(2)

University of California, San Farncisco

San Francisco, California, United States

Aravind Eye Institute

Pondicherry, Tamil Nadu, India

View Full Details on ClinicalTrials.gov

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NCT06658002